MAUDE Adverse Event Report: APEX HEALTHCARE MFG INC BIOCLINIC LOW AIR LOSS SYSTEM; AIR MATTRESS AND PUMP

Model Number BIOLAL-3680-M

Device Problem Material Separation (1562)

Patient Problem Pressure Sores (2326)

Event Date 01/01/2015

Event Type  Injury  

Event Description

It was reported to the manufacturer by the end use, per the end user the pt sustained pressure ulcers while using the bioclinic air mattress.The caregiver stated that the hose crumbled and was not working.The pt was seen by the general practitioner for the pressure ulcers.The bioclinic mattress and control unit were replaced with a dermafloat mattress and control unit.(b)(4) were entered into out system to have the mattress and pump returned to joerns for investigation.As of this writing, the mattress and pump has been received and is being investigated.

Manufacturer Narrative

Joerns sending the report to the manufacturer.

• Brand Name: BIOCLINIC LOW AIR LOSS SYSTEM
• Type of Device: AIR MATTRESS AND PUMP
• Manufacturer (Section D): APEX HEALTHCARE MFG INC; min hsiung; chi yi ; TW
• Manufacturer Contact: felicia banks ; 2100 design rd; arlington, TX 76014 ; 8008260270
• MDR Report Key: 4766612
• MDR Text Key: 5796637
• Report Number: 3009402404-2015-00008
• Device Sequence Number: 1
• Product Code: FNM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 04/02/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: BIOLAL-3680-M
• Device Catalogue Number: BIOLAL-3680-M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2015
• Distributor Facility Aware Date: 01/01/2015
• Device Age: 18 MO
• Event Location: Home
• Date Report to Manufacturer: 04/02/2015
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 38 YR
• Patient Weight: 118